BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPLEX 2200

    MDR report key: 15853697 · Received November 23, 2022

    Report

    Report Number
    1000135116-2022-00002
    Event Type
    Malfunction
    Date Received
    November 23, 2022
    Date of Event
    October 18, 2022
    Report Date
    November 23, 2022
    Manufacturer
    BIO-RAD LABORATORIES, INC
    Product Code
    NSU
    UDI-DI
    00847865002813
    PMA / PMN Number
    BK140112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BIOPLEX 2200 IS CONNECTED TO INPECO LABORATORY AUTOMATION SYSTEM (TLA) AT (B)(6) IN SPAIN. ON OCTOBER 19TH, 2022, BIO-RAD TECHNICAL SUPPORT RECEIVED AN EMAIL FROM THE CUSTOMER THAT A SAMPLE WAS ADDED TO THE QUEUE FOR SAMPLING ON BIOPLEX AND AN ERROR OCCURRED. 2 SAMPLES THAT WERE BEHIND THE FIRST SAMPLE WERE NOT MOVED TO THE GATING AREA OF THE BIOPLEX, BUT BIOPLEX SHOWED SAMPLES ARE IN PROCESS. THE INCIDENT WAS DETECTED BY THE TESTING LABORATORY AND RESULTS WERE NOT REPORTED TO THE PATIENT. ADDITIONALLY, WE HAVE CONFIRMED THAT WHEN THE INCIDENT OCCURS THE TRACK LINE SYSTEM REPORTS A "RED STATE" ERROR WARNING WHICH IS PRESENTED AT THE USER INTERFACE. PER THE TRACK LINE INTERFACE IFU (0U00000165-EN-US.10), THIS ERROR INDICATES THAT THE COMMUNICATION BETWEEN ANALYZER AND AUTOMATION SYSTEM HAS BEEN INTERRUPTED OR THE ANALYZER IS IN ERROR CONDITION. USER INTERVENTION IS REQUIRED TO RECOVER FROM THIS ERROR CONDITION WHICH RENDERS THESE INCIDENTS AS DETECTABLE. ON OCTOBER 24TH, 2022, BIO-RAD TECHNICAL SUPPORT PERSONNEL ESCALATED THE CASE AS A POTENTIAL ADVERSE EVENT. SOFTWARE ENGINEERS FROM INPECO AND BIO-RAD ARE EVALUATING EVENT LOGS AND INVESTIGATING THE ROOT CAUSE FOR THIS ISSUE.

    Description of Event or Problem · 0

    THE BIOPLEX IS CONNECTED TO A INPECO LABORATORY AUTOMATION SYSTEM (TLA). A SAMPLE WAS ADDED TO THE QUEUE FOR SAMPLING ON BIOPLEX AND AN ERROR OCCURRED. 2 SAMPLES THAT WERE BEHIND THE FIRST SAMPLE WERE NOT MOVED TO THE GATING AREA OF THE BIOPLEX, BUT BIOPLEX SHOWED SAMPLES ARE IN PROCESS. THE INCIDENT WAS DETECTED BY THE TESTING LABORATORY AND RESULTS WERE NOT REPORTED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291807 BIOPLEX 2200 INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS, PRODUCT CODE: NSU NSU BIO-RAD LABORATORIES, INC BIOPLEX 2200 00847865002813

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other